CHRONIC HEPATITIS C TREATMENT EXPANSION Generic Manufacturing for Developing Countries

Gilead is working to enable access to its medicines for all people who can benefit from them, regardless of where they live or their economic means.

Snapshot

Gilead has agreements with There are an estimated 71 Gilead also offers its branded 14 companies to manufacture million people living with hepatitis C medicines at a generic hepatitis C medicines for hepatitis C worldwide single, significantly reduced 105 developing countries price across these countries

For more than a decade, Gilead has been working with governments, healthcare systems, providers, public health entities and generic manufacturers to make its HIV and hepatitis B medicines available worldwide. Currently, more than10 million people living with HIV in developing countries receive Gilead antiretroviral medicines through these efforts. Gilead is also working to help ensure broad access to its hepatitis C medicines in developing countries.

Gilead has voluntary licensing agreements with 11 -based generic pharmaceutical manufacturers to develop the hepatitis C (HCV) compounds sofosbuvir, ledipasvir, velpatasvir and voxilaprevir for distribution in 105 developing countries. Gilead also has agreements with local generic manufacturers for in-country production and distribution of our HCV medicines in Egypt and Pakistan.

Generic Agreements Under the agreements, Gilead’s generic licensees have the right to develop and market generic versions of Gilead HCV medicines in certain developing countries. The companies may set their own prices and receive a complete technology transfer of the Gilead manufacturing process, enabling them to scale up production as quickly as possible. Licensees also pay a royalty to Gilead that supports overall developing world product registration, medical education and training, safety monitoring and other business activities.

International Licensees In-Country Licensees

Aurobindo Pharma Ltd. Mylan Laboratories Ltd. Ferozsons Laboratories Ltd. (Pakistan) Limited Ltd. Magic Pharma (Egypt) Ltd. SeQuent Scientific Ltd. Pharmed Healthcare (Egypt) Cipla Ltd. Strides Shasun Ltd. Hetero Labs Ltd. Sun Pharmaceuticals Pvt. Ltd. Industries Ltd.

November 2017 www.gilead.com

The licensing agreement encompasses the following countries: Afghanistan Chad Guatemala Maldives Palau Suriname Algeria Comoros Guinea Mali Papua New Guinea Swaziland Angola Congo, DR Guinea-Bissau Marshall Islands Paraguay Tajikistan Antigua and Congo, Rep. Guyana Mauritania Philippines Tanzania Barbuda Cook Islands Haiti Mauritius Rwanda Thailand Bangladesh Cote d’Ivoire Honduras Micronesia Samoa Timor-Leste Belarus Cuba India Mongolia Sao Tome & Pr. Togo Benin Djibouti Indonesia Morocco Senegal Tonga Bhutan Dominica Kenya Mozambique Seychelles Tunisia Bolivia Egypt Kiribati Myanmar Sierra Leone Turkmenistan Botswana El Salvador Kyrgyz Republic Namibia Solomon Islands Tuvalu Burkina Faso Equatorial Guinea Lao PDR Nauru Somalia Uganda Burundi Eritrea Lesotho Nepal South Africa Ukraine Cambodia Ethiopia Liberia Nicaragua South Sudan Uzbekistan Cameroon Fiji Libya Niger Sri Lanka Vanuatu Cape Verde Gabon Madagascar Nigeria St. Vincent and the Vietnam Central African Gambia Malawi North Korea Grenadines Zambia Republic Ghana Malaysia Pakistan Sudan Zimbabwe

Chronic Hepatitis C Treatment Expansion Challenges Providing HCV treatment in resource-limited settings presents complex challenges. For example, many countries have limited or no HCV “Curative treatments that are screening, lack the healthcare infrastructure to care for significant more efficacious and less toxic numbers of patients and do not have the diagnostic capacity to test for than ever before have the the diverse range of genotypes requiring different treatment regimens. potential to dramatically reduce Public and policymaker awareness of the disease is limited, as is the health and economic national and international funding for HCV screening and treatment. burdens associated with HCV infection around the world. The opportunity to address Working Locally to Advance Access the massive HCV pandemic is Generic manufacturing is just one component of scaling up HCV now within reach and a global treatment. Also critical are in-country activities that support drug movement is needed to create availability and use, including product registration, medical and clinical generalized access to HCV education, demand forecasting and collaborative research. Gilead treatment in high-, middle- and works with a global network of regional business partners on these low-income countries. This will require political will, financial activities. investment, and support from pharmaceutical, medical and • Product Registration: Regional business partners help manage civil society organizations national registration processes for Gilead’s branded HCV products. around the world.” They also assist with pharmacovigilance and safety reporting once – WHO Guidelines for the registrations are obtained. Screening, Care and • Public Health and Medical Education: Gilead and regional business Treatment of Persons with partners conduct public health and medical education events with Hepatitis C Infection, 2014 doctors and other healthcare providers in developing countries, to increase their knowledge of disease burden and impact, as well as viral hepatitis treatment options and their appropriate use for patients. • Demand Forecasting: Ensuring an uninterrupted supply of medicine requires accurately forecasting product demand. Gilead has invested in proprietary information tools to track orders and inventory across regions and prevent disruptions in supply. • Collaborative Research: National trials for sofosbuvir, ledipasvir and velpatasvir are underway or planned in several developing countries.

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